How to upgrade a pharmaceutical production line

Never underestimate the importance of keeping up to date with evolutions of pharmaceutical production lines. In order to deliver products with the highest quality and thus guarantee patient safety, every packaging or aseptic filling line should consistently be reevaluated and modified where needed.




What do we mean by upgrading a production line?


It can be:

  • Revamping an existing production line or part of it

  • Adding new equipment to an existing production line

  • Introducing new format/recipe to an existing production line


Reasons to upgrade a production line

  • As part of the obsolescence management

  • To make the production line more reliable and/or more efficient

  • To comply with (new) regulations

  • Readiness for filling/packaging a new product / standardisation across production sites

Nowadays, quite a lot of lines run on obsolete systems. The most critical components regarding obsolescence are computer-based systems, PLCs and vision systems. Today, the technology is evolving so fast that sometimes suppliers are struggling to guarantee the availability of spare parts during the usual time period of 10 years.

On a 20-year old system, the hardware is most probably not available anymore and the risk of failure has increased. No like-to-like change is possible anymore. Also, these older systems usually don’t comply with today’s ERES and Data Integrity requirements.

The worst case would be the failure of an obsolete system that has no technical documentation and no spare parts in stock. Even if you have a valuable technician in your maintenance team who knows this machine by heart, you still need to be lucky enough to find the last spare part available somewhere in the world!

Sometimes an upgrade is urgently required in order to avoid a line breakdown. This is the opportunity to fix all of these issues at once.

Other motives for a line upgrade can be the strategy to have a backup line (example: backup of another production site of the same global company) or to make the line ready to process a new product.

Yet another motive can just be to increase the speed of the line or to improve the operation of the line. This requires a thorough analysis of the existing line and of the mid and long-term plans of the company.



What are the risks of not doing it?

  • Breakdown of the entire production line because of missing spare parts

  • Low output of the production line

  • Non compliance

  • No opportunity to grow

The balance between cost and risk (safety, quality, …) must be evaluated. For some upgrades, the added value is obvious. For some others, there is no clear cut between upgrading the existing line or buying a complete new line. It all depends on the “preventive” maintenance action that is required to avoid a possible outage and/or on the business strategy that is chosen.



Who are the stakeholders?

  • Preferably, the supplier of the machine. If not, an experienced integrator

  • Engineering department

  • Automation department

  • Validation department

  • QA

  • Users

  • Maintenance

  • All other department, depending on the modification


How to start?

  • Evaluate the potential impact on the product(s) file

  • Evaluate the potential impact on the supply chain

  • Evaluate the impact on maintenance works

  • Evaluate the impact on production procedures

  • Demonstrate the added value and have the project endorsed by management

  • Initiate the Change Control document

As usual, in the pharmaceutical industry, many different stakeholders are involved in the Change Control process. All aspects must be evaluated before the Change Control can be approved. This is the first step, and it can also be the longest one.



Following steps

Once the project has been initiated, the next steps can take place within planning and budget:

  • Translation of the requirements into the design

  • Delivery of documents

  • Implementation

  • Commissioning

  • Validation / Qualification


Impacted lifecycle documents:

  • URS

  • Design documents (FS, HDS, SDS, drawings, …)

  • Validation protocols

  • Qualification protocols

  • Validation plan

  • Periodic review



Conclusion


Do not take unnecessary risks. Making continuous process improvements and implementing upgrades guarantees a return on investment. In the case of obsolescence, you will solve all your issues of spare parts availability, compliance, documentation, reliability, etc. In all other cases, you will also improve the line efficiency and tailor it to your needs.

pi can provide experts and services for this kind of activities in the pharmaceutical industry and will be happy to help you with the upgrade of your production line(s).






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